# K926508: Intrasite Gel

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew United, Inc.
- Decided: Jul 13, 1993 after 195 days
- Product code: NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic)
- Device class: 1
- Regulation: 21 CFR 878.4022
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971597: Comfeel Purilon Gel,15G (3900)/Comfeel Purilon Gel,25G (3903) (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K926508
Methodology: https://510kreport.com/methodology